The pros and cons of Prolia, Amgen's new osteoporosis drug June 14, 2010 ![]()
Overall a well done and informative story - although it did not always use the absolute risk/benefit statistics that we prefer. Our Review Summary
The story detailed what is known about the impact of this drug on various types of bone fractures associated with osteoporosis, how its mode of action is someone different than other osteoporosis treatments, its administration and how the costs compare with other treatments. The one shortcoming of the story was that it had elements of disease-mongering, as explained below.
Why This Matters: The gestalt about osteoporosis is that women should live in fear of bone breaks. While the story provided very good information about this new treatment, it did not provide much context about the problem. And its inconsistent use of relative vs. absolute risk/benefit data didn't help. Click on Criteria for definitions. The story opens with a statement about this drug's approval by the FDA. ![]() Discuss costs? - SATISFACTORY
This story not only mentions the cost for this drug but also for other treatments for osteoporosis as well. ![]() Avoid "disease-mongering"? - NOT SATISFACTORY
The story only indicated lifetime risks of fracture (i.e. 1 out of every 2 women over the age of 50) and that 25% of people die within 5 years of breaking a hip without providing some context for these concerns. The 5 year risk of fracture for a woman aged 55 is not the same as that for a woman aged 75; similarly, there are other factors compounding the statistic about death following hip fracture. ![]() Evaluate the quality of evidence? - SATISFACTORY
The story provided information about the clinical trial it described, including the number of people studied, the length of time they were studied and the impact on various types of fractures. ![]() Quantify the potential harms? - SATISFACTORY
The story gave a rather complete listing of the potential harms associated with the use of this drug, including specific mention of those problems that are unique to this drug as compared with other medications used to manage bone loss. Although the list was complete, the story did not indicate the frequency with which these harms occurred. Nonethless, we'll give the story the benefit of the doubt on this criterion. The story provided a useful explanation of how this medication differed from the other treatments available for osteoporosis. ![]() Quantify the potential benefits? - SATISFACTORY
The story did a great job of distinguishing among various fracture types and reporting both relative and absolute risk reduction for vertebra fracture. But then it was disappointing that the risk reduction for hip fractures and that of wrist, leg, or shoulder were reported as only relative risk reduction. Since the story characterized hip fractures as 'devastating', it should have provided the reader with some sense of how frequently they occur rather than simply indicating how often they result in a person entering a nursing home or dying within 5 years of having one. Nonethless, because of the elements that were well done, we'll give the story the benefit of the doubt on this criterion. ![]() Appear to rely solely or largely on a news release? - SATISFACTORY
Does not appear to rely exclusively on a news release. ![]() Use independent sources and identify conflicts of interest? - SATISFACTORY
Comments about this drug and its potential utility from two clinicians noted as not having industry ties to this or other osteoporosis drugs were included in this story. ![]() Compare the new approach with existing alternatives? - SATISFACTORY
This story compared the benefits, harms and costs for the new drug, with those treatments already on the market. Total Score: 9 of 10 Satisfactory The U.S. Preventive Services Task Force is considered the gold standard of preventive health recommendations - including on screening tests. It's a good source for journalists and consumers.
About 70% of the stories reviewed from 2006-9 failed to adequately discuss costs, or to explain how big (or small) are the potential benefits and harms of treatments, tests, products and procedures.
We have documented a disturbing trend of news stories taking an advocacy stance, promoting certain screening tests outside the boundaries of scientific evidence.
Stories on new technologies like Cyberknife, DaVinci robotic surgery systems, and proton beam cancer therapy often fail to scrutinize the evidence and/or to discuss the costs involved.
Rather than suggesting that everyone should be screened for everything, news stories could explain: "All screening tests cause harm; some may do good."
The first 38 network TV network morning health news stories reviewed in 2009 earned an average score of 1.2 stars. 13 of the 38 stories got ZERO stars.
Both TIME magazine and BusinessWeek have published terrific stories explaining the importance of the Number Needed to Treat - or NNT.
Knowing relative risk reduction is like knowing you have a 50% off coupon but not knowing whether it's for a Lexus or a lollipop. Absolute risk reduction tells you what the "coupon" is worth. Read more.
The website NoFreeLunch.org posts "a database of health care professionals who have pledged to accept no gifts from industry and to rely on non-promotional sources of information."
To help journalists cover stories responsibly, we post a list of independent experts who state that they do not have financial ties to drug or medical device manufacturers.
We apply the same ten standardized criteria to the review of every story.
We have about 30 story reviewers. Each story is reviewed by 3 different people.
Gary Schwitzer's seven words you shouldn't use in medical news: cure, miracle, breakthrough, promising, dramatic, hope, victim. Read why.
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